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NCT05933525 · ClinicalTrials.gov registry record · Phase 2
Clinical Study to Assess the Efficacy of IMM-124E (Travelan®) in a Controlled Human Infection Model
A Phase 2 study of Diarrhea and Travelers' Diarrhea, sponsored by Immuron.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05933525: Completed Phase 2 study of Diarrhea and Travelers' Diarrhea, sponsored by Immuron.
NCT05933525 is a Phase 2 study of Diarrhea and Travelers' Diarrhea that has completed, run by Immuron. The registered enrollment target is 60 participants, below the 155-participant average among 24 other Diarrhea trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05933525, a Phase 2 study of Diarrhea and Travelers' Diarrhea, has completed, sponsored by Immuron.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized, double-blind, placebo-controlled study to investigate if Travelan® protects healthy adult volunteers from moderate-to-severe diarrhea upon challenge with Enterotoxigenic Escherichia coli (ETEC) strain H10407.
Primary Outcome
The number of subjects who encounter moderate to severe diarrhea (defined as ≥4 Grade 3-5 stools in any 24-hour period post-challenge or ≥401 grams of Grade 3-5 stools in the 5-day period post-challenge) will be recorded for the Travelan group and the placebo group. All stool samples will be collected, weighed and graded. Stool grading scale: Grade 1 = Fully formed (normal) Grade 2 = Soft (normal) Grade 3 = Thick liquid (diarrheal) Grade 4 = Opaque watery (diarrheal) Grade 5 = Rice-water (dia
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Travelan
Study Locations (1)
Maryland
- Pharmaron Clinical Pharmacology Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-05-29 |
| Est. Completion | 2024-12-30 |
| Phase | Phase 2 |
What the finished NCT05933525 record still lists
NCT05933525 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 155-participant average among 24 other Diarrhea trials with a reported enrollment target (61% lower).
The record links to 3 conditions, with Diarrhea appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05933525 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05933525 about?
NCT05933525 is a clinical study titled "Clinical Study to Assess the Efficacy of IMM-124E (Travelan®) in a Controlled Human Infection Model". This is a randomized, double-blind, placebo-controlled study to investigate if Travelan® protects healthy adult volunteers from moderate-to-severe diarrhea upon challenge with Enterotoxigenic Escherichia coli (ETEC) strain H10407.
What is the current status of trial NCT05933525?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2023-05-29. Estimated completion is 2024-12-30.
What conditions does trial NCT05933525 study?
This clinical trial studies the following conditions: Diarrhea, Travelers' Diarrhea, Infectious Diarrhea.
What interventions are being tested in trial NCT05933525?
The interventions under investigation include: Placebo (OTHER), Travelan (BIOLOGICAL).
Who is sponsoring clinical trial NCT05933525?
This trial is sponsored by Immuron, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05933525 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diarrhea
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05933525's enrollment target sits among peer trials
60 9th of 24 higher than 14 of 24 other Diarrhea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diarrhea trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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